Injury or disease which affects the larynx in some situations requires surgical treatment. In extreme cases where resection or reconstruction of the larynx is required, it is conventionally known to use a structure (generally referred to as a "stent") conforming to the internal configuration of the larynx to support the larynx during healing. Laryngeal stents are generally inserted by surgical procedures, but may, in some situations, be inserted through an endoscopic tube. These stents may remain in place for two to four weeks or longer depending on the patient and/or the type of surgery performed. Laryngeal stents known heretofore have been solid, and formed from a biocompatible polymer material When positioned within the larynx, the stent eliminates the ability to speak and more importantly, cuts off air to the lungs. In this respect, a tracheotomy must be performed to enable the patient to breathe, and a T-tube or tracheotomy tube is generally used in conjunction with the stent for as long as the stent is in place in the patient.
A primary function of the larynx is to prevent saliva and other material from entering the lungs via the trachea. Accordingly, stents are dimensioned or formed to conform snuggly to the inner shape of the larynx. Typically, such stents include an enlarged upper portion shaped to generally conform to and engage the surface of the epiglottis. The enlarged upper portion is crowned and tapered downwardly generally along the lines of the aryepiglogtic ligament of the larynx. This upper, crowned portion of the stent is thus operative to divert saliva and other matter towards the esophagus and away from the larynx, trachea and the lungs. From this enlarged upper portion, the stent tapers to a generally cylindrical lower portion which is positioned within the upper portion of the trachea. In the vicinity of the vocal cords, grooves extending from the anterior portion to the posterior portion of the stent are provided on opposite sides thereof to receive the vocal cords.
As set forth above a T-tube or tracheotomy tube is required as long as the stent is in place. In this respect, the T-tube or tracheotomy tube projects through an opening in the tracheal wall to enable the patient to breath. This necessary arrangement, i.e., a stent together with a T-tube or tracheotomy tube, produces several undesirable conditions in the patient. For example, these devices, i.e., the T-tube or tracheotomy tube, create a restriction to normal breathing, and are susceptible to a build-up or a crusting of mucus, dust and moisture on the internal surfaces thereof which further reduces air flow. At instances of high air flow, primarily when the patient coughs, the inability of the tube to transmit increased airflow creates a pressure build-up which acts against the stent and tends to force it upwards. Such violent movement may break sutures and rupture or damage the surgically repaired structure of the trachea and/or larynx. In another respect, the stent-tube arrangement damages the tracheal wall. Normal inhaling and exhaling by the patient produces movement of the tube, which movement abrades the tracheal wall where the tube passes therethrough. In this respect, inhalation and exhalation also produces a similar effect on the stent, thus producing a movement within the larynx which abrades the lining thereof.
Another problem associated with stents known heretofore relates to the comfort of the patient. In this respect, conventionally known stents are generally positioned and maintained in place within the patient by sutures fastened to the stent which extend through the patient's laryngeal cartilages and skin where they are secured by additional sutures. It is also known to secure stents in place with sutures through the nose or mouth. The sutures traumatize the cartilages and skin, which leads to infection, granulation tissue, and scarification, all of which are very uncomfortable for the patient especially when the stent remains in place for prolonged periods of time. Moreover, the stents are solid and relatively rigid, and are a highly irritative and traumatic obstruction within the patient's throat. Perhaps the most important problem associated with stents known heretofore is that they prohibit the patients ability to communicate. In this respect, because the stent necessarily traverses the vocal cords, the patient is unable to produce sound.
The present invention overcomes these and other problems and provides a device that permits venting of high pressure build-ups which may occur below the larynx, enables the patient to produce sound, and prevents seepage of matter into the lungs via the larynx and the trachea. Moreover, the present invention eliminates the need for sutures to secure the stent in place, and provide a more natural, comfortable feeling for the patient.